RecruitingNot ApplicableNCT04217603

Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC

Effect of Continuous Positive Airway Pressure (CPAP) on 6-Minute Walk Test Outcomes in Patients With Excessive Central Airway Collapse (ECAC)


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

32 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this protocol is to perform a prospective, randomized, double-blinded, pacebo-controlled clinical trial to determine the influence of a non-invasive positive pressure ventilation device on exercise capacity and symptoms in adult patients with ECAC. Primary outcome will include the total distance traversed by the study subject during a standard 6-minute walk test, and secondary outcomes will include peak flow measurement and symptom reporting before and after the exercise testing. The study will focus on the use of continuous positive airway pressure (CPAP) device. CPAP is FDA-approved for the treatment of various medical conditions, including obstructive sleep apnea and heart failure, but is not FDA-approved for the treatment of ECAC. The study will enroll 32 ambulatory study subjects with confirmed ECAC at the BIDMC, and each study subject will be monitored for up to 3 months.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether CPAP (continuous positive airway pressure) — a device that delivers pressurized air to keep airways open — can improve exercise tolerance in patients with excessive central airway collapse (ECAC), a condition where the large airways in the chest collapse during breathing, causing shortness of breath, reduced exercise capacity, and frequent lung infections. ECAC is often underdiagnosed, and many patients also have other breathing problems. Standard treatment involves bronchoscopy (airway inspection) or sometimes airway stenting, but CPAP may offer a non-invasive way to keep airways open during exercise, improving the 6-minute walk test — a standard measure of exercise capacity. You may be eligible if: - You are over 18 years old - You have been diagnosed with ECAC by bronchoscopy or CT scan - You have never used a CPAP device before - You are scheduled for bronchoscopy as part of your standard care - You have a baseline 6-minute walk test result available You may NOT be eligible if: - You have poorly controlled asthma, COPD, obstructive sleep apnea, GERD, or relapsing polychondritis - You have a significant heart arrhythmia or resting heart rate below 50 beats per minute - You cannot walk more than 140 meters in 6 minutes - You cannot tolerate bronchoscopy under sedation or anesthesia - You have a known allergy to bronchoscopy medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEContinuous positive airway pressure (CPAP) device

Use of a CPAP during a 6 minute walk test to maintain the airways open during the respiratory cycle

DEVICESham-continuous positive airway pressure (CPAP) device

An enlarged air leak incorporated into the exhalation valve will be positioned between the mask and the CPAP tubing, allowing airflow resistance of the exhalation port to be almost eliminated by increasing its area, thereby virtually cancelling positive pressure. Also an orifice restrictor in the CPAP circuit will be connected between the CPAP unit and the tubing in order to load the blower with the same airflow resistance as in true CPAP.


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04217603


Related Trials